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Electrolyte

Magnesium Sulfate for Bronchiolitis

Phase 2 & 3

Waitlist Available

Led By John W Berkenbosch, MD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Less than 24 hours of admission to the PICU

Admitted to the pediatric intensive care unit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours post bolus of medication versus placebo

Awards & highlights

Study Summary

This trial will evaluate the effect of magnesium sulfate on bronchiolitis, a common respiratory illness in infants.

Who is the study for?

This trial is for infants under 12 months old with moderate to severe bronchiolitis, admitted to the pediatric intensive care unit within the last 24 hours. Parents must consent for their child's participation. Infants with cyanotic heart disease, chronic lung disease, or unrepaired congenital heart disease cannot participate.Check my eligibility

What is being tested?

The study tests how a single dose of magnesium sulfate affects infants with bronchiolitis in terms of breathing and overall respiratory health. It also looks at any side effects and safety concerns associated with this treatment.See study design

What are the potential side effects?

While not specified here, common side effects of magnesium sulfate may include flushing, sweating, lowered blood pressure, confusion, and slowed breathing in some cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted to the Pediatric Intensive Care Unit less than 24 hours ago.

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I am currently in the pediatric intensive care unit.

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My child is under 1 year old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours post bolus of medication versus placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours post bolus of medication versus placebo

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours post bolus of medication versus placebo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the effect of this therapy on clinical respiratory status

Secondary outcome measures

Identify the incidence of adverse effects and safety profile of magnesium sulfate

Side effects data

From 2012 Phase 4 trial • 200 Patients • NCT01342510

30%

Pain with injection of propofol

100%

80%

60%

40%

20%

Study treatment Arm

Lidocaine/Magnesium

Control

Lidocaine

Magnesium

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Magnesium SulfateExperimental Treatment1 Intervention

The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes.

Group II: PlaceboPlacebo Group1 Intervention

The patient will receive a bolus of Normal Saline over twenty minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnesium Sulfate

2011

Completed Phase 4

~5160

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,944 Total Patients Enrolled

1 Trials studying Bronchiolitis

72 Patients Enrolled for Bronchiolitis

John W Berkenbosch, MDPrincipal InvestigatorUniversity of Louisville

Media Library

Magnesium Sulfate (Electrolyte) Clinical Trial Eligibility Overview. Trial Name: NCT04740294 — Phase 2 & 3

Bronchiolitis Research Study Groups: Placebo, Magnesium Sulfate

Bronchiolitis Clinical Trial 2023: Magnesium Sulfate Highlights & Side Effects. Trial Name: NCT04740294 — Phase 2 & 3

Magnesium Sulfate (Electrolyte) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04740294 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum eligibility age for this study greater than eighteen years?

"As indicated by the study's inclusion criteria, prospective participants must be between 1 Month and 12 Months old. Additionally, there are 34 clinical studies available for minors and 32 medical trials accessible to elderly patients over 65 years of age."

Answered by AI

What is the capacity of this trial in terms of patient enrollment?

"Affirmative. The trial is actively looking for participants, according to the information found on clinicaltrials.gov. This investigation was first posted on July 21st 2021 and has been recently updated on December 13th 2021; it requires 40 subjects from a single site."

Answered by AI

What type of individuals are ideal for recruiting into this experiment?

"This clinical trial is recruiting 40 infants aged between 1 and 12 months that have been diagnosed with viral bronchiolitis. In addition to these criteria, participants must also be admitted in the pediatric intensive care unit for less than 24 hours, exhibit moderate/severe symptoms according to MPIS standards, and obtain parental/legal guardian consent prior to participation."

Answered by AI

What are the primary medicinal purposes of Magnesium Sulfate?

"Magnesium Sulfate is routinely used to treat hypomagnesemia, as well as for countering the effects of poisoning and prophylactically treating against magnesium deficiency. Additionally, this medication may assist with contusions."

Answered by AI

Are any participants being recruited for this clinical trial at present?

"Affirmative, according to the clinicaltrials.gov database this trial is still open for recruitment. This research opportunity was first published on July 21st 2021 and recently updated in December 13th 2021; 40 patients are required from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

John W Berkenbosch 2021. "Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04740294.

All > Bronchiolitis